ID

37942

Beschreibung

A Study of Herceptin (Trastuzumab) in Combination With a Taxane in Patients With HER2-Positive Breast Cancer Who Relapsed After (Neo)Adjuvant Herceptin Treatment; ODM derived from: https://clinicaltrials.gov/show/NCT01301729

Link

https://clinicaltrials.gov/show/NCT01301729

Stichworte

Versionen (1)
  1. 02.09.19 02.09.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

2. September 2019

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01301729

Englisch

Eligibility Breast Cancer NCT01301729

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
female patients, >/= 18 years of age
Beschreibung

Gender | Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
locally recurrent/metastatic breast cancer (relapse in supra- or infraclavicular lymph nodes is regarded as metastatic disease)
Beschreibung

Breast cancer recurrent Locally | Secondary malignant neoplasm of female breast

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0278493
UMLS CUI [1,2]
C1517927
UMLS CUI [2]
C0346993
her2-positive primary disease
Beschreibung

Disease HER2 Positive

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2348909
patients must have received herceptin in the adjuvant and/or neoadjuvant setting
Beschreibung

Herceptin | Adjuvant therapy | Neoadjuvant Therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0338204
UMLS CUI [2]
C0677850
UMLS CUI [3]
C0600558
relapsed breast cancer >/= 6 months after discontinuing last drugs of herceptin and/or chemotherapy in the adjuvant and/or neoadjuvant setting for her2-positive breast cancer
Beschreibung

Breast cancer recurrent | Status post Herceptin Discontinuation | Status post Adjuvant Chemotherapy | Status post Neoadjuvant Chemotherapy | HER2-positive carcinoma of breast

Datentyp

boolean

Alias
UMLS CUI [1]
C0278493
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C0338204
UMLS CUI [2,3]
C1444662
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C0085533
UMLS CUI [4,1]
C0231290
UMLS CUI [4,2]
C0600558
UMLS CUI [4,3]
C3665472
UMLS CUI [5]
C1960398
measurable disease according to recist 1.0
Beschreibung

Measurable Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C1513041
eastern cooperative oncology group (ecog) performance status 0-2
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
maximum cumulative dose of doxorubicin </= 360 mg/m2 or of epirubicin </= 720 mg/m2 or no prior anthracyclines
Beschreibung

Doxorubicin Cumulative Dose Maximum | Epirubicin Cumulative Dose Maximum | Anthracyclines Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013089
UMLS CUI [1,2]
C2986497
UMLS CUI [1,3]
C0806909
UMLS CUI [2,1]
C0014582
UMLS CUI [2,2]
C2986497
UMLS CUI [2,3]
C0806909
UMLS CUI [3,1]
C0282564
UMLS CUI [3,2]
C0332197
at least 3 weeks after prior surgery or radiotherapy
Beschreibung

Operative Surgical Procedure Previous | Prior radiation therapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0205156
UMLS CUI [2]
C0279134
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant or breastfeeding women
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
previous chemotherapy for metastatic breast cancer (prior endocrine therapy till progressive disease is allowed)
Beschreibung

Prior Chemotherapy Secondary malignant neoplasm of female breast

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0346993
pleural effusions, ascites or bone lesions as only manifestation of disease
Beschreibung

Pleural effusion disorder | Ascites | Bone lesion

Datentyp

boolean

Alias
UMLS CUI [1]
C0032227
UMLS CUI [2]
C0003962
UMLS CUI [3]
C0238792
brain metastases
Beschreibung

Metastatic malignant neoplasm to brain

Datentyp

boolean

Alias
UMLS CUI [1]
C0220650
invasive malignancy other than metastatic breast cancer
Beschreibung

Invasive cancer | Exception Secondary malignant neoplasm of female breast

Datentyp

boolean

Alias
UMLS CUI [1]
C0677898
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0346993
inadequate bone marrow, hepatic or renal function
Beschreibung

Bone Marrow function Inadequate | Liver function Inadequate | Renal function Inadequate

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [1,3]
C0205412
UMLS CUI [2,1]
C0232741
UMLS CUI [2,2]
C0205412
UMLS CUI [3,1]
C0232804
UMLS CUI [3,2]
C0205412
prior treatment with anti-her therapies other than (neo)adjuvant herceptin
Beschreibung

HER Receptors Targeted Therapy | Exception Herceptin Neo-adjuvant

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3812393
UMLS CUI [1,2]
C2985566
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0338204
UMLS CUI [2,3]
C1298676
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Ähnliche Modelle

Eligibility Breast Cancer NCT01301729

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
female patients, >/= 18 years of age
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Breast cancer recurrent Locally | Secondary malignant neoplasm of female breast
Item
locally recurrent/metastatic breast cancer (relapse in supra- or infraclavicular lymph nodes is regarded as metastatic disease)
boolean
C0278493 (UMLS CUI [1,1])
C1517927 (UMLS CUI [1,2])
C0346993 (UMLS CUI [2])
Disease HER2 Positive
Item
her2-positive primary disease
boolean
C0012634 (UMLS CUI [1,1])
C2348909 (UMLS CUI [1,2])
Herceptin | Adjuvant therapy | Neoadjuvant Therapy
Item
patients must have received herceptin in the adjuvant and/or neoadjuvant setting
boolean
C0338204 (UMLS CUI [1])
C0677850 (UMLS CUI [2])
C0600558 (UMLS CUI [3])
Breast cancer recurrent | Status post Herceptin Discontinuation | Status post Adjuvant Chemotherapy | Status post Neoadjuvant Chemotherapy | HER2-positive carcinoma of breast
Item
relapsed breast cancer >/= 6 months after discontinuing last drugs of herceptin and/or chemotherapy in the adjuvant and/or neoadjuvant setting for her2-positive breast cancer
boolean
C0278493 (UMLS CUI [1])
C0231290 (UMLS CUI [2,1])
C0338204 (UMLS CUI [2,2])
C1444662 (UMLS CUI [2,3])
C0231290 (UMLS CUI [3,1])
C0085533 (UMLS CUI [3,2])
C0231290 (UMLS CUI [4,1])
C0600558 (UMLS CUI [4,2])
C3665472 (UMLS CUI [4,3])
C1960398 (UMLS CUI [5])
Measurable Disease
Item
measurable disease according to recist 1.0
boolean
C1513041 (UMLS CUI [1])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status 0-2
boolean
C1520224 (UMLS CUI [1])
Doxorubicin Cumulative Dose Maximum | Epirubicin Cumulative Dose Maximum | Anthracyclines Absent
Item
maximum cumulative dose of doxorubicin </= 360 mg/m2 or of epirubicin </= 720 mg/m2 or no prior anthracyclines
boolean
C0013089 (UMLS CUI [1,1])
C2986497 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C0014582 (UMLS CUI [2,1])
C2986497 (UMLS CUI [2,2])
C0806909 (UMLS CUI [2,3])
C0282564 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Operative Surgical Procedure Previous | Prior radiation therapy
Item
at least 3 weeks after prior surgery or radiotherapy
boolean
C0543467 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0279134 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
pregnant or breastfeeding women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Prior Chemotherapy Secondary malignant neoplasm of female breast
Item
previous chemotherapy for metastatic breast cancer (prior endocrine therapy till progressive disease is allowed)
boolean
C1514457 (UMLS CUI [1,1])
C0346993 (UMLS CUI [1,2])
Pleural effusion disorder | Ascites | Bone lesion
Item
pleural effusions, ascites or bone lesions as only manifestation of disease
boolean
C0032227 (UMLS CUI [1])
C0003962 (UMLS CUI [2])
C0238792 (UMLS CUI [3])
Metastatic malignant neoplasm to brain
Item
brain metastases
boolean
C0220650 (UMLS CUI [1])
Invasive cancer | Exception Secondary malignant neoplasm of female breast
Item
invasive malignancy other than metastatic breast cancer
boolean
C0677898 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0346993 (UMLS CUI [2,2])
Bone Marrow function Inadequate | Liver function Inadequate | Renal function Inadequate
Item
inadequate bone marrow, hepatic or renal function
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0205412 (UMLS CUI [1,3])
C0232741 (UMLS CUI [2,1])
C0205412 (UMLS CUI [2,2])
C0232804 (UMLS CUI [3,1])
C0205412 (UMLS CUI [3,2])
HER Receptors Targeted Therapy | Exception Herceptin Neo-adjuvant
Item
prior treatment with anti-her therapies other than (neo)adjuvant herceptin
boolean
C3812393 (UMLS CUI [1,1])
C2985566 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0338204 (UMLS CUI [2,2])
C1298676 (UMLS CUI [2,3])
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